The FDA's Approval of Gazyva for Follicular Lymphoma

The FDA's Approval of Gazyva for Follicular Lymphoma

For those diagnosed in the early stages of follicular lymphoma and are lacking symptoms, the oncologist may choose to not treat the cancer right away. Instead, he/she may opt to classify the lymphoma as one requiring just ‘active surveillance’ for the time being. In this case, the patient would be closely monitored and not treated until symptoms occur. Survival outcomes for those on surveillance watch is similar to those who are treated for early stages of the disease.

However, since FL has no major symptoms in its early stages, people with FL are commonly not diagnosed until they are in the late stages of the disease. At this point, it’s important to start treatment as soon as possible.

FDA Approval of the New Drug That is Said to Work Even Better Than Retuxan for Follicular Lymphoma (from Pipeline Review/PLR)

On the heels of approval for the Retuxan Hycela combo drug came approval for the new drug, Gazyva, offering a new treatment option for FL!

The FDA has approved Gazyva as the first line of defense for those with advanced follicular lymphoma who have not received any other treatment for the disease.

It’s approved for patients with stage 2 ‘bulky’, 3 or 4 FL. (CURE)

Gazyva approval for treatment of those with previous unsuccessful treatment with rituxan or for those who have relapsed

In February 2016, the FDA had also approved Gazyva plus the chemotherapy agent bendamustine. This combo drug is approved to treat “people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen or whose follicular lymphoma returned after such treatment (DHHS)"

2017 Gazyva approval for first-line treatment

Regarding the 2017 Gazyva approval: (it) “is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

Gazyva is on the market in the U.S.

Even though Gazyva has been found to surpass the effectiveness of treatment when compared to Retuxan, the two cancer-treatment drugs are similar in many respects.

Similarities of Gazyva and Retuxan

Gazyva and Retuxan share similarities.

Both drugs are categorized as ‘engineered’ monoclonal antibodies, CD20-directed, for targeted use in treating FL.

These ‘man-made’ antibodies attach to a protein found on certain types of lymphocytic B-cells, responsible for manufacturing antibodies in the body’s attempt toward off the cancerous cells.

These engineered antibodies are thought to attack the targeted cancer cells, both directly and together with the body’s immune system, causing the cancerous cells to disintegrate.

Both monoclonal antibodies have approval to be given with the addition of chemotherapy drugs to boost their effectiveness.

Read on to learn more about Gazyva and its implications when it comes to follicular lymphoma treatment.

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